Regulatory

Services

Key Services

Design and implementation of regulatory submission strategy
Collection and preparation of key submission documents
Development of country specific submissions package
Localization of master ICF
Preparation and submission of clinical trial application
Submission and notification of substantial and non-substantial protocol amendments
Management of communications with regulatory agencies and ethics committees
Responses to regulatory body requests for information
End of trial notifications, submission of country specific requirements
Regulatory project management including management of timelines and oversight of free-lancers and other third parties
Support in other study registration activities (local registries)
Facilitation of submission of compassionate use programs, early access and named patient programs